Human Participants Research at the University of Northern Iowa

Human Participants Human Participants Research at theResearch at the

University of Northern IowaUniversity of Northern Iowa

Information for Students, Information for Students, Faculty & Staff at UNIFaculty & Staff at UNI

ObjectivesObjectives

Understand the historical context in which Understand the historical context in which the ethical principles of research evolved. the ethical principles of research evolved.

Know the ethical principles governing Know the ethical principles governing human research (the “Belmont principles”).human research (the “Belmont principles”).

Understand how to apply the ethical Understand how to apply the ethical principles to one’s own research.principles to one’s own research.

Understand the role of the IRB and how to Understand the role of the IRB and how to navigate the IRB review process.navigate the IRB review process.

Nazi Medical Experiments in WWII Nazi Medical Experiments in WWII Concentration CampsConcentration Camps

International ResponseInternational Response

Nuremburg War Trials

German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.”

Nuremberg Code - 1947Nuremberg Code - 1947

As part of the verdict, the Court enumerated ten As part of the verdict, the Court enumerated ten rules for “Permissible Medical Experiments”, rules for “Permissible Medical Experiments”, now known as the “Nuremberg Code”. Among now known as the “Nuremberg Code”. Among others, the rules include:others, the rules include:

Voluntary consent is absolutely essentialVoluntary consent is absolutely essential Benefits outweigh risksBenefits outweigh risks Ability of the subject to terminate participationAbility of the subject to terminate participation

Did the Nuremberg Code Impact Did the Nuremberg Code Impact the behavior of American the behavior of American

scientists who did research on scientists who did research on humans?humans?

NoNo

Well Known Cases Involving Well Known Cases Involving Unethical or Questionable Research Unethical or Questionable Research

in the U.S.in the U.S.

Tuskegee Syphilis Study: 1932-1972Tuskegee Syphilis Study: 1932-1972Guatemalan Syphilis Study: 1946-1948Guatemalan Syphilis Study: 1946-1948U.S. Radiation Experiments: 1944-1974U.S. Radiation Experiments: 1944-1974Willowbrook Study: 1956-1972Willowbrook Study: 1956-1972Milgram Authority/Conformity Study: 1961Milgram Authority/Conformity Study: 1961Jewish Chronic Disease Hospital: 1963Jewish Chronic Disease Hospital: 1963Zimbardo’s Stanford Prison Study: 1971Zimbardo’s Stanford Prison Study: 1971Tearoom Trade Study: 1970 Tearoom Trade Study: 1970

Tuskegee Syphilis Study (1932-72)Tuskegee Syphilis Study (1932-72)

American medical research project American medical research project conducted by the U.S. Public conducted by the U.S. Public Health Service from 1932 to 1972 Health Service from 1932 to 1972 examined the natural course of examined the natural course of untreated syphilis in black men. untreated syphilis in black men. The subjects, impoverished The subjects, impoverished sharecroppers from Macon sharecroppers from Macon County, Alabama, were unknowing County, Alabama, were unknowing participants in the study; they were participants in the study; they were not told that they had syphilis, nor not told that they had syphilis, nor were they offered effective were they offered effective treatment after a cure was found.treatment after a cure was found.

Guatemalan Syphilis Study Guatemalan Syphilis Study (1946-48)(1946-48)

U.S. Public Health U.S. Public Health employees purposefully employees purposefully infected over 1300 infected over 1300 prostitutes, prisoners, mental prostitutes, prisoners, mental patients, and soldiers in patients, and soldiers in Guatemala with STDs Guatemala with STDs without their knowledge. without their knowledge. Only some were treated, and Only some were treated, and 83 may have died as a result 83 may have died as a result of the diseases.of the diseases.

US National Research Act of 1974US National Research Act of 1974

Revelations of Tuskegee Study resulted in Revelations of Tuskegee Study resulted in Senate investigation into research activitiesSenate investigation into research activitiesLed to passage of National Research ActLed to passage of National Research ActEstablished National Commission for the Established National Commission for the Protection of Human SubjectsProtection of Human SubjectsBelmont Report – 1979Belmont Report – 1979 Ethical Principles and Guidelines for the Protection of

Human Subjects of Research

Code of Federal Regulations – 45 CFR 46Code of Federal Regulations – 45 CFR 46 Creation of IRBs

Basic Principles of Belmont ReportBasic Principles of Belmont Report

Respect for persons Respect for persons Proclaims individuals capable of self-determination; Proclaims individuals capable of self-determination;

thus voluntary consent is essential (autonomy)thus voluntary consent is essential (autonomy)

BeneficenceBeneficence Obligates researchers to maximize potential benefits Obligates researchers to maximize potential benefits

and minimize possible harmand minimize possible harm

JusticeJustice Requires the benefits and burdens of research be Requires the benefits and burdens of research be

fairly distributedfairly distributed

Federal Regulations for the Protection Federal Regulations for the Protection of Subjects from Research Risksof Subjects from Research Risks

45 CFR Part 4645 CFR Part 46Common RuleCommon Rule

1981/1991/20051981/1991/2005

Federal Regulations and PolicyFederal Regulations and Policy

Additional Protections Included in 45 CFR 46:Additional Protections Included in 45 CFR 46:

Subpart BSubpart B - Additional Protections for - Additional Protections for Pregnant Pregnant WomenWomen, Human Fetuses and Neonates Involved , Human Fetuses and Neonates Involved in Research in Research (revised December 13, 2001)(revised December 13, 2001)

Subpart CSubpart C - Additional DHHS Protections - Additional DHHS Protections Pertaining to Biomedical and Behavioral Pertaining to Biomedical and Behavioral Research Involving Research Involving PrisonersPrisoners as Subjects as Subjects

Subpart DSubpart D - Additional DHHS Protections for - Additional DHHS Protections for ChildrenChildren Involved as Subjects in Research Involved as Subjects in Research

Federalwide Assurance (FWA)Federalwide Assurance (FWA)

What is an Institutional Assurance?What is an Institutional Assurance? Issued by the Office for Human Research Issued by the Office for Human Research Protections (OHRP) … the federal agency Protections (OHRP) … the federal agency regulating research involving humansregulating research involving humansDocumentation of institutional commitment to Documentation of institutional commitment to comply with the Common Rulecomply with the Common RuleCertifies that Certifies that all researchall research with human with human participants conducted at UNI will be reviewed participants conducted at UNI will be reviewed for approval by the IRB in accordance with for approval by the IRB in accordance with federal regulationsfederal regulations

Definition of ResearchDefinition of Research

A systematic investigation, including A systematic investigation, including research development, testing and research development, testing and evaluation, evaluation, designed todesigned to contribute to contribute to generalizable knowledgegeneralizable knowledge

Generalizable knowledge is interpreted to include research findings or data intended for public dissemination or presentation in any form, including via the Internet, poster presentation, scholarly paper, or report to external sponsor. The definition also includes research undertaken by students for the purpose of independent research papers, theses or dissertations.

Definition of Human Definition of Human ParticipantParticipant

A human participant is a A human participant is a livingliving individual individual about whomabout whom an investigator (whether an investigator (whether professional or student) conducting professional or student) conducting research obtains: research obtains:

(1)(1) data through intervention or interaction data through intervention or interaction with the individual, or with the individual, or

(2)(2) identifiable private informationidentifiable private information

Thus, the scope of “human participant" is interpreted broadly. If you are Thus, the scope of “human participant" is interpreted broadly. If you are interviewing people, testing individuals, looking at records, or conducting a interviewing people, testing individuals, looking at records, or conducting a

survey, you are involving human participants in your research.survey, you are involving human participants in your research.

Which projects need review?Which projects need review?

CRITERIA 1CRITERIA 1

Is it research?Is it research?

• Systematic data collection

• Intended to contribute to generalizable knowledge

• Results will be made public (e.g., presentation, research article, Internet, report)


CRITERIA 2 CRITERIA 2 Is it research with Is it research with human subjects? human subjects?

• A living individual about whom an investigator … conducting research obtains:

1. data through intervention or interaction with the individual or

2. identifiable private information


Examples of projects needing review:Examples of projects needing review:Mailed survey to ascertain opinions on a topic

Action research project in a local school

Testing athletes’ physiological response to running

Conducting interviews of Postville residents to obtain opinions of economic climate following the ICE raid

An investigator obtains individually identifiable information on the treatment outcomes of patients and records data in a coded manner

Teacher utilizes student artifacts and test results collected the previous semester


Examples of projects Examples of projects notnot needing review: needing review:Program evaluation or quality improvement projects for internal use onlyClass research projects (results not shared outside of class)

No more than minimal risk Adults not from a vulnerable population

Data collection about organizations No personal opinions/data

Surveys performed as contracted services to inform business decisions in which results are not made publicObservations of public behavior in which there is no interaction with those being observed

Does this project require IRB review?Does this project require IRB review?

The Department of Residence at UNI conducts The Department of Residence at UNI conducts activities on campus during the summer for activities on campus during the summer for incoming students. DOR asks participants to incoming students. DOR asks participants to complete a satisfaction survey at the end of complete a satisfaction survey at the end of each session. This information is used by the each session. This information is used by the director in planning future orientation sessions.director in planning future orientation sessions.

NO – it is intended to evaluate the orientation NO – it is intended to evaluate the orientation program and is not collecting data that will program and is not collecting data that will contribute to generalizable knowledgecontribute to generalizable knowledge


A staff member wishes to know whether UNI A staff member wishes to know whether UNI students are committed to the university by students are committed to the university by wearing clothing with the UNI name or logo on it. wearing clothing with the UNI name or logo on it. She positions herself in a prominent location at She positions herself in a prominent location at the Union and counts the number of students the Union and counts the number of students wearing UNI clothing for an hourwearing UNI clothing for an hour

NO – it is observation of public behavior. The NO – it is observation of public behavior. The staff member is not interacting with subjects, nor staff member is not interacting with subjects, nor is she obtaining private information.is she obtaining private information.


An investigator hopes to understand business An investigator hopes to understand business outcomes for individuals who lost their outcomes for individuals who lost their businesses to the floods of 2008. To do this, PI businesses to the floods of 2008. To do this, PI conducts interviews with a sample of business conducts interviews with a sample of business owners from Cedar Rapids.owners from Cedar Rapids.

YES – it is a systematic investigation designed YES – it is a systematic investigation designed to contribute to generalizable knowledge. to contribute to generalizable knowledge. Further, it involves interaction with the subjects Further, it involves interaction with the subjects and gathers private information.and gathers private information.


A faculty member wishes to understand more A faculty member wishes to understand more about attitudes of patrons of a local business about attitudes of patrons of a local business regarding Christmas shopping. With the regarding Christmas shopping. With the permission of the store owner, the researcher permission of the store owner, the researcher stands on the public sidewalk outside the store stands on the public sidewalk outside the store and asks customers to complete a short survey. and asks customers to complete a short survey.

YES – it is a systematic investigation designed YES – it is a systematic investigation designed to contribute to generalizable knowledge. to contribute to generalizable knowledge. Further, it involves interaction with the subjects Further, it involves interaction with the subjects and gathers private information.and gathers private information.


For a senior thesis, a student has access to an For a senior thesis, a student has access to an existing dataset from a local business s/he is existing dataset from a local business s/he is assisting. The dataset contains individual-level assisting. The dataset contains individual-level private information pertaining to company private information pertaining to company employees. employees.

YES – such projects require review. Several YES – such projects require review. Several questions relate. Is the dataset publically questions relate. Is the dataset publically available? Can personal identities be available? Can personal identities be established? Is the data coded? Special established? Is the data coded? Special application for projects involving existing data. If application for projects involving existing data. If any questions, contact the IRB.any questions, contact the IRB.

What if you aren’t sure if the project What if you aren’t sure if the project requires IRB review!requires IRB review!

IF …IF … there is a questionthere is a question a project might become researcha project might become research there is potential to publish or presentthere is potential to publish or present

THEN …THEN … submit to the IRBsubmit to the IRB at least ask!at least ask!

Institutional Review Board: Institutional Review Board: Role and ResponsibilitiesRole and Responsibilities

Disapproving a study at UNI is very rare, but Disapproving a study at UNI is very rare, but modifications are commonmodifications are common

What is the IRB?What is the IRB?Authorized by federal regulationsAuthorized by federal regulations

A committee charged with the review of A committee charged with the review of human participants research to assure human participants research to assure that the participants’ rights and welfare that the participants’ rights and welfare are adequately protectedare adequately protected

Researchers are responsible for obtaining Researchers are responsible for obtaining IRB review and approval before their IRB review and approval before their research commencesresearch commences

IRB CompositionIRB Composition

At least 5 membersAt least 5 members

Scientific and Nonscientific MembersScientific and Nonscientific Members

At least 1 Non-affiliated MemberAt least 1 Non-affiliated Member

Collective Expertise Collective Expertise

Sensitivity to Community StandardsSensitivity to Community Standards

Diversity of PerspectivesDiversity of Perspectives

Knowledge of Vulnerable Subjects Knowledge of Vulnerable Subjects

The UNI IRBThe UNI IRBIn Office of Sponsored Programs (OSP)In Office of Sponsored Programs (OSP)

Institutional Official – Christy TwaitInstitutional Official – Christy Twait Assistant Provost for Sponsored ProgramsAssistant Provost for Sponsored Programs

IRB Administrator – Anita GordonIRB Administrator – Anita Gordon

Interdisciplinary CommitteeInterdisciplinary Committee Chair, Helen HartonChair, Helen Harton

UNI’s Full BoardUNI’s Full BoardBunker, Dr. Matthew P. -- UNI Department of Marketing (2009-2014)Bunker, Dr. Matthew P. -- UNI Department of Marketing (2009-2014)

Clohesy, Dr. William W. -- UNI Philosophy & World Religions (2008-2014)Clohesy, Dr. William W. -- UNI Philosophy & World Religions (2008-2014)

Creighton-Smith, Belinda -- Prisoner Advocate (2009-2012)Creighton-Smith, Belinda -- Prisoner Advocate (2009-2012)

Downs, Dr. William R. -- UNI Department of Social Work (2010-2014)Downs, Dr. William R. -- UNI Department of Social Work (2010-2014)

Etscheidt, Dr. Susan K. -- UNI Special Education (2009-2012)Etscheidt, Dr. Susan K. -- UNI Special Education (2009-2012)

Evans, Dr. Todd -- UNI HPELS-Athletic Training (2009-2012)Evans, Dr. Todd -- UNI HPELS-Athletic Training (2009-2012)

Gordon, Anita, M.S.W. -- UNI IRB Administrator (Ongoing)Gordon, Anita, M.S.W. -- UNI IRB Administrator (Ongoing)

Harton, Dr. Helen C. -- UNI Psychology (2007-2013) (Chair)Harton, Dr. Helen C. -- UNI Psychology (2007-2013) (Chair)

Hensley, Dr. Larry D. -- Community Member (2010-2013)Hensley, Dr. Larry D. -- Community Member (2010-2013)

Larimer, Dr. Christopher -- UNI Political Sciences (2011-2013)Larimer, Dr. Christopher -- UNI Political Sciences (2011-2013)

Ophus, Dr. John -- UNI Biology & Science Education (2011-2013)Ophus, Dr. John -- UNI Biology & Science Education (2011-2013)

Roth, Dr. Ronald R. -- Community Member (2008-2014)Roth, Dr. Ronald R. -- Community Member (2008-2014)

Stalp, Dr. Marybeth – UNI Sociology, Anthropology & Criminology (2011-2013)Stalp, Dr. Marybeth – UNI Sociology, Anthropology & Criminology (2011-2013)

Criteria for IRB ApprovalCriteria for IRB Approval

Risks to participants are minimizedRisks to participants are minimized Risks are reasonable in relation to anticipated Risks are reasonable in relation to anticipated

benefitsbenefits Selection of participants is equitableSelection of participants is equitable Informed consent is sought from each Informed consent is sought from each

prospective participantprospective participant Informed consent is appropriately documentedInformed consent is appropriately documented When appropriate, data are monitored to When appropriate, data are monitored to

ensure safety of participantsensure safety of participants When appropriate, privacy and confidentiality of When appropriate, privacy and confidentiality of

participants is protectedparticipants is protected

Additional Protections for Vulnerable Additional Protections for Vulnerable PopulationsPopulations

ChildrenChildren Parent/guardian permission is generally Parent/guardian permission is generally

required for people under age 18required for people under age 18PrisonersPrisonersPregnant womenPregnant womenMentally disabled personsMentally disabled personsEconomically or educationally disadvantaged Economically or educationally disadvantaged personspersonsOthersOthers

Types of IRB ReviewTypes of IRB Review

Exempt from Continuing ReviewExempt from Continuing ReviewExpeditedExpeditedFull BoardFull Board

Modifications to Approved ProtocolsModifications to Approved ProtocolsContinuing Review (Annual)Continuing Review (Annual)

Exempt from Exempt from Continuing Review Continuing Review

Minimal risk Minimal risk

Often includes anonymous surveys and archival Often includes anonymous surveys and archival observationsobservations

Review usually takes less than 2 weeksReview usually takes less than 2 weeks

Does not require continuing approvalDoes not require continuing approval

Changes to protocol DO require prior approvalChanges to protocol DO require prior approval

Review IS requiredReview IS required

Minimal riskMinimal risk

May include surveys/measures in which May include surveys/measures in which participant is identifiedparticipant is identified

Review usually takes about 2 weeks Review usually takes about 2 weeks

DOES require closure/continuing review forms DOES require closure/continuing review forms (usually 1 year period) (usually 1 year period)

Changes to protocol DO require prior approvalChanges to protocol DO require prior approval

ExpeditedExpedited

Full Board ReviewFull Board ReviewMore than minimal risk studiesMore than minimal risk studiesOften includes vulnerable populationsOften includes vulnerable populationsMay include deceptionMay include deceptionReviewed by full committee at monthly meetingReviewed by full committee at monthly meetingInvestigators may attend but not required (is Investigators may attend but not required (is recommended)recommended)Plan ahead - review will take longer for these!Plan ahead - review will take longer for these!

Minimal RiskMinimal Risk

Minimal riskMinimal risk means that the probability and means that the probability and magnitude of harm or discomfort magnitude of harm or discomfort anticipated in the research are not greater anticipated in the research are not greater in and of themselves than those ordinarily in and of themselves than those ordinarily encountered in daily life or during the encountered in daily life or during the performance of routine physical or performance of routine physical or psychological examinations or tests.psychological examinations or tests.

Protections Protections Required:Required:

RecruitmentRecruitment

Recruitment IssuesRecruitment Issues

Equitable selection of participantsEquitable selection of participants

Minimize possibility of coercion or undue Minimize possibility of coercion or undue influence: “an offer you can’t refuse”influence: “an offer you can’t refuse” Indirect recruitment, third party Indirect recruitment, third party

recruitment, assurancesrecruitment, assurances

Participants’ relationship to PI Participants’ relationship to PI

CompensationCompensation

CompensationCompensationCompensation Compensation ≠≠ benefits benefitsPayment to participants for the time, Payment to participants for the time, inconvenience, and expenses involved in inconvenience, and expenses involved in participating in a research projectparticipating in a research project Monetary, gift cards, property … t-shirts, books, etcMonetary, gift cards, property … t-shirts, books, etc Considered a recruitment incentive Considered a recruitment incentive

Total payments ≥ $600 reported to IRS Total payments ≥ $600 reported to IRS Individual payments > $74 requires PI to record name, Individual payments > $74 requires PI to record name,

SSN, address and report to OBOSSN, address and report to OBO UNI employees or students – UNI employees or students – allall compensation must be compensation must be

submitted to OBO (and possibly financial aid)submitted to OBO (and possibly financial aid) Implications for informed consentImplications for informed consent

Students as Students as ParticipantsParticipants

Same issues related to employees, Same issues related to employees, patients, or those subordinate to the patients, or those subordinate to the researcherresearcher

Because of potential for coercion or undue Because of potential for coercion or undue influence, there is possibility that agreement influence, there is possibility that agreement to participate will not be freely givento participate will not be freely given

Whenever possible, PIs Whenever possible, PIs should avoidshould avoid using using their own students or employees as their own students or employees as research subjectsresearch subjects

Action, ethnographic, and Action, ethnographic, and qualitative researchqualitative research

Practitioner researchers do not have right to Practitioner researchers do not have right to demand or compel participation in research demand or compel participation in research (Pritchard, 2002)(Pritchard, 2002)

Qualitative research requires sustained, on-going Qualitative research requires sustained, on-going negotiation to informed consent and participationnegotiation to informed consent and participation


Risks MinimizedRisks Minimized

Possible RisksPossible RisksPhysicalPhysical

PsychologicalPsychological

SocialSocial

EmotionalEmotional

EconomicEconomic

PoliticalPolitical

Invasion of privacyInvasion of privacy

Loss of confidentialityLoss of confidentiality

EmbarrassmentEmbarrassment

FinancialFinancial

Stress/discomfortStress/discomfort

OtherOther

Risks to ParticipantsRisks to ParticipantsRisks must be reasonable in relation Risks must be reasonable in relation to the benefitsto the benefits

IRB must weigh the benefits of the IRB must weigh the benefits of the research against the potential risks to research against the potential risks to subjectssubjects

No risks vs. No No risks vs. No foreseeableforeseeable risks risks


Confidentiality/PrivacyConfidentiality/Privacy

Privacy and ConfidentialityPrivacy and Confidentiality““When appropriate, there are adequate When appropriate, there are adequate provisions to protect the privacy of provisions to protect the privacy of subjects and to maintain the confidentiality subjects and to maintain the confidentiality of data”of data”

Breaches of privacy and/or confidentiality Breaches of privacy and/or confidentiality are the main risk in social-behavioral are the main risk in social-behavioral research or research that is no greater research or research that is no greater than minimal risk.than minimal risk.

ConfidentialityConfidentiality

Maintain confidentiality of research data Maintain confidentiality of research data

Methods may include:Methods may include: Coding identifiers, limiting access to research Coding identifiers, limiting access to research

data, storing data safely throughout the study, data, storing data safely throughout the study, destroying data upon completion of the study, destroying data upon completion of the study, encryption, and training the research team on the encryption, and training the research team on the importance of confidentiality importance of confidentiality

Remember that several “vague” identifiers Remember that several “vague” identifiers (e.g., gender and race) together may (e.g., gender and race) together may individually identify participantsindividually identify participants

Confidentiality on the InternetConfidentiality on the Internet

Application to Internet-based research Application to Internet-based research and online surveysand online surveys

Statement on consent document should Statement on consent document should advise participants that no absolute advise participants that no absolute guarantee can be made about the guarantee can be made about the confidentiality of data sent via the confidentiality of data sent via the Internet. Internet.


Informed ConsentInformed Consent

Informed ConsentInformed ConsentRespect for Persons or AutonomyRespect for Persons or Autonomy Fundamental principle from Belmont ReportFundamental principle from Belmont Report Individuals empowered to make free Individuals empowered to make free

decisions, and given adequate information to decisions, and given adequate information to make good decisionsmake good decisions

Arguably, the most important ethical Arguably, the most important ethical principle in researchprinciple in research

Informed Consent:Informed Consent:Criteria for IRB ApprovalCriteria for IRB Approval

According to federal regulations ….According to federal regulations ….

1.1. Informed consent will be sought from Informed consent will be sought from each prospective subject each prospective subject (46.116)(46.116)

2.2. Informed consent will be appropriately Informed consent will be appropriately documented documented (46.117)(46.117)

Informed ConsentInformed ConsentA process not a form!A process not a form!

No coercion or undue influence No coercion or undue influence (recruitment)(recruitment)

Language understandable to the Language understandable to the participantparticipant

No exculpatory languageNo exculpatory language

8 required elements of consent8 required elements of consent

6 additional elements, where appropriate6 additional elements, where appropriate

What would you want What would you want to know if you were a to know if you were a research participant?research participant?

Required ElementsRequired Elements

1.1. Statement that the study is research and Statement that the study is research and explanation of purposes and proceduresexplanation of purposes and procedures

Duration, location, procedures, etc.Duration, location, procedures, etc.

2.2. Reasonably foreseeable risks or discomforts Reasonably foreseeable risks or discomforts

3.3. Benefits which may be reasonably expectedBenefits which may be reasonably expected

4.4. Alternative procedures or treatments Alternative procedures or treatments

5.5. Statement about confidentiality of dataStatement about confidentiality of data

Required Elements (cont.)Required Elements (cont.)

6.6. If more than minimal risk … statement If more than minimal risk … statement regarding compensation for injuriesregarding compensation for injuries

7.7. Contact information Contact information Usually PI and IRB Administrator Usually PI and IRB Administrator

8.8. Statement that participation is voluntary and Statement that participation is voluntary and one can withdraw at any time without penaltyone can withdraw at any time without penalty

Informed consent documents should be on UNI letterhead or state that research is being conducted by faculty/students/staff at UNI.

Types of ConsentTypes of ConsentVarious methodsVarious methods

A written consent document or formA written consent document or form OrallyOrally Electronically presentedElectronically presented Presented in a letterPresented in a letter

Waiver of documentation of consentWaiver of documentation of consent Consent information still providedConsent information still provided

Parental permission required for childrenParental permission required for children No passive consent allowedNo passive consent allowed

Do I have to interact with Do I have to interact with the IRB again post-the IRB again post-

review?review?

YES!YES!

When Further Contact with When Further Contact with IRB is RequiredIRB is Required

Changes to protocolChanges to protocol

Continuing approvalContinuing approval

ClosureClosure

Adverse eventsAdverse events

Changes to ProtocolsChanges to ProtocolsChanges to all studies, even those exempt from continuing Changes to all studies, even those exempt from continuing review, must be approved by IRBreview, must be approved by IRB

When risks or protections changeWhen risks or protections change Participant pool changesParticipant pool changes Procedures changeProcedures change Consent document changes Consent document changes Instrument changesInstrument changes Research sites changeResearch sites change

Email request to IRB Administrator Email request to IRB Administrator Include original protocol # Include original protocol # Attach any new/changed materialsAttach any new/changed materials Forwarded to reviewerForwarded to reviewer

Continuing ApprovalContinuing ApprovalApproval period no longer than 1 yearApproval period no longer than 1 year

PI must seek continuing approval PI must seek continuing approval No grace periodNo grace period

Applies to Full Board or Expedited studiesApplies to Full Board or Expedited studies

Use Annual/Update formUse Annual/Update form

Form and reminder email sent out by IRB Form and reminder email sent out by IRB office 30 days before expiration datesoffice 30 days before expiration dates

Project ClosureProject Closure

Download form from IRB websiteDownload form from IRB website

Send in any time after completion of studySend in any time after completion of study

Important for students to remember before Important for students to remember before they leave campusthey leave campus

Adverse EventsAdverse EventsFederal regulations require PIs report to Federal regulations require PIs report to the IRB problems or adverse events that the IRB problems or adverse events that occur during course of studyoccur during course of study

IRB required to report to OHRPIRB required to report to OHRP Unanticipated problemsUnanticipated problems Serious or continuing noncompliance by PISerious or continuing noncompliance by PI Suspension or termination of a studySuspension or termination of a study

IRB Review ProcessIRB Review Process

Initiate acomplete application,

with all supportingdocuments

Exempt, expedited or FBreview

Changes as needed leading to final approval

Administrative review

PI receives reviewer

comments

Renewal/amendment or closure

Start

IRB FormsIRB FormsStandard Application

Survey ApplicationSurvey Application

Existing Data ApplicationExisting Data Application

Annual Renewal/Update formAnnual Renewal/Update form

Project Closure formProject Closure form

Informed Consent ChecklistInformed Consent Checklist

Supplemental Materials Supplemental Materials May IncludeMay Include

Recruitment letters/scriptsRecruitment letters/scriptsCopies of instrumentsCopies of instrumentsConsent documentsConsent documentsLetters of cooperationLetters of cooperationDebriefing scripts Debriefing scripts Training certificatesTraining certificates Required for all key personnelRequired for all key personnel

How to Find UsHow to Find Us

Office of Sponsored ProgramsOffice of Sponsored Programs www.uni.edu/osp - Click on Research Policies - Click on Research Policies 213 East Bartlett Hall213 East Bartlett Hall

[email protected] or 273-6148 or 273-6148

[email protected] or 273-2235 or 273-2235

Questions?Questions?Thank You!Thank You!

Documents

Human Participants Research at the University of Northern Iowa